A Multiple Dose Study of Debio 1450 [Intravenous (IV) and Oral] in Healthy Volunteers

Summary

Debio 1450-103 is a trial to study the pharmacokinetics (PK) of an experimental drug called Debio 1450 in healthy adult volunteers. Originally, Part A was registered separately (in NCT02214355). The registrations have been revised so all parts of this single trial (Parts A-C) are now included in this single registration (NCT02214433).

The primary purpose of each part is provided below:

* 10 volunteers participate in PART A to assess the PK of a single oral dose of Debio 1450 (tablet formulation) under varying gastric conditions
* 40 volunteers participate in PART B to assess the safety, tolerability and PK of multiple ascending doses of Debio 1450, administered sequentially IV and orally, once or twice daily.
* An additional 10 volunteers participate in PART C which is designed to assess the absolute bioavailability of various formulations of Debio 1450 under varying gastric conditions

The dose administered during Part A is based on the safety, tolerability and PK data from study Debio 1450-102 \[NCT02162199\], a single ascending dose (SAD) study, in which single oral doses up to 800 mg/day are being investigated. Doses are adjusted during Parts B and C based on the available safety and PK data from preceding cohorts.

Conditions

• Bacterial Infections

Interventions

DRUG

Placebo IV Solution

A sterile IV solution of 5% dextrose in water

DRUG

Debio 1450 IV Solution

A white to off-white powder (40 mg Debio 1450 per vial) to be reconstituted and formulated in a sterile IV solution of 5% dextrose in water

DRUG

Placebo Tablet or Capsule

Placebo tablet or capsule, matching Debio 1450 coated tablet or capsule

DRUG

Debio 1450 Tablet

Debio 1450 40 mg coated tablets

DRUG

Debio 1450 Capsule

Debio 1450 40 mg capsules

DRUG

Debio 1450 Oral Solution

Lyophilized Debio 1450 (40 mg per vial) reconstituted in 5% dextrose in water

DRUG

Pantoprazole

Pantoprazole 40 mg orally

Sponsors & Collaborators

• Debiopharm International SA

  lead INDUSTRY

Principal Investigators

• Frederick Wittke, MD · Debiopharm International SA

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2014-08-31

Primary Completion

2015-02-28

Completion

2015-02-28

Countries

• United States

Study Locations